The CardioClip Study (CardioClip)

January 27, 2024 updated by: Nir Uriel, Columbia University

Hemodynamic-Guided Optimization With the CardioMEMS Device of Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Mitral Transcatheter Edge-to-Edge Repair With the MitraClip Device

The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with heart failure suffer considerably. They experience an increased risk of death and are hospitalized with symptoms of heart failure frequently. Often times, heart failure results in abnormal function of the mitral valve (one of the key valves separating the heart's main pumping chamber - the left ventricle - from the left atrium, which collects oxygenated blood from arteries in the lung). This abnormal function causes the valve to leak - a condition called mitral regurgitation - that perpetuates and can exacerbate heart failure.

Recently, researchers have developed a procedure for patients with mitral regurgitation in the setting of heart failure called mitral transcatheter edge-to-edge repair (mTEER). In this procedure, a "clip" is deployed to grasp the mitral valve leaflet and re-approximate them, thereby reducing the amount of mitral regurgitation. This procedure is performed by accessing one of the large veins in the body and no surgical intervention is required. Patients typically recover within 24 hours and are discharged home without the prolonged recovery periods associated with traditional therapies for mitral regurgitation like open heart surgery and mitral valve repair or replacement. Moreover, the procedure is exceedingly safe, with a very low risk of significant adverse complications.

While mTEER reduces the risk of death and hospitalization for heart failure compared with the standard of care (i.e., medicines geared at improving heart function), many patients still suffer significant adverse events within a five year period. Accordingly, the investigators are interested in identifying strategies to further improve outcomes for patients with heart failure and significant mitral regurgitation. The CardioClip study endeavors to use another technology - a wireless pulmonary artery pressure sensor - that is implanted in a similar fashion to the way mTEER is performed (i.e., percutaneously, without surgery, through one of the veins in the groin), to see whether clinical outcomes can be improved further. The sensor continuously transmits information regarding heart function to clinicians who can optimize medications and their doses according to dynamic changes in pressure noted by the sensor.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
        • Principal Investigator:
          • Nir Uriel, MD
        • Contact:
        • Sub-Investigator:
          • Michael Brener, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Significant (moderate-severe [3+] or severe [4+] secondary MR)
  • Left ventricular dysfunction (ejection fraction >20% and <50%)
  • New York Heart Association (NYHA) class II-IVa symptoms
  • Sign informed consent to participate in the study

Exclusion Criteria:

  • Left ventricular (LV) end-systolic dimension 70 mm
  • PA systolic pressure 70 mmHg (fixed)
  • Mitral valve (MV) orifice area <4.0 cm2
  • Commissural MR jet or leaflet anatomy not suitable for mTEER
  • Likely to undergo heart transplantation or LV assist device implantation in the next 12 months
  • Recurrent (i.e., >1) pulmonary embolism or deep vein thrombosis
  • Complex congenital heart disease
  • Mechanical right heart valve (tricuspid or pulmonic)
  • Cardiac resynchronization therapy implanted within 3 months of enrollment
  • Hypersensitivity to aspirin and/or clopidogrel
  • History of medication non-adherence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CardioMems
Participants randomized to this arm will receive hemodynamic-guided GDMT titration with CardioMems.
Device: CardioMEMS
Hemodynamic-guided optimization will be performed using the CardioMEMS CardioClip device.
No Intervention: Usual Care
Participants randomized to this arm will receive usual care involving GDMT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause-mortality or heart failure hospitalization (HFH)
Time Frame: 12 months
A composite sum of all-cause mortality and heart failure hospitalization events will be calculated.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality rate at 12 months
Time Frame: 12 months
All-cause mortality rate will be calculated at 12 months.
12 months
All-cause mortality rate at 24 months
Time Frame: 24 months
All-cause mortality rate will be calculated at 24 months.
24 months
Rate of HFH at 12 months
Time Frame: 12 months
Heart failure hospitalization (HFH) rate will be calculated.
12 months
Rate of HFH at 24 months
Time Frame: 24 months
Heart failure hospitalization (HFH) rate will be calculated.
24 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months
Time Frame: 12 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. To facilitate interpretation, all scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life (i.e., higher score indicates a better outcome).
12 months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 12 months
Time Frame: Baseline and 12 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. To facilitate interpretation, all scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life (i.e., higher score indicates a better outcome).
Baseline and 12 months
6-minute walk test (6MWT) at 12 months
Time Frame: 12 months
The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. The score of the test is the distance a patient walks in 6 minutes at 12 months.
12 months
Change in 6-minute walk test (6MWT) from baseline to 12 months
Time Frame: Baseline and 12 months
The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. The score of the test is the distance a patient walks in 6 minutes. Change of score at baseline and then at 12 months will be calculated.
Baseline and 12 months
Echocardiographic estimates of RV-PA coupling indices
Time Frame: 12 months
Right ventricular (RV)-pulmonary arterial (PA) (RV-PA) coupling indices will be measured (mm/mmHg) will be measured to determine how the right ventricle and pulmonary circulation interact.
12 months
N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Time Frame: 12 months
Natriuretic Peptides: Median (with interquartile range) of NT-proBNP (pg/mL) will be calculated.
12 months
C-Reactive Protein (CRP)
Time Frame: 12 months
Inflammatory Marker: Median (with interquartile range) of CRP (mg/dL) will be calculated.
12 months
Erythrocyte Sedimentation Rate (ESR)
Time Frame: 12 months
Inflammatory Marker: Median (with interquartile range) of ESR (mn/hour) will be calculated.
12 months
Matrix Metalloproteinase-2 (MMP-2)
Time Frame: 12 months
Matric Remodeling Proteins: Median (with interquartile range) of MMP-2 (ng/mL) will be calculated.
12 months
Matrix Metalloproteinase-9 (MMP-9)
Time Frame: 12 months
Matric Remodeling Proteins: Median (with interquartile range) of MMP-9 (ng/mL) will be calculated.
12 months
Device-related (MitraClip) complications at 12 (single-leaflet device detachment, device embolization, endocarditis requiring surgery, mitral stenosis requiring surgery)
Time Frame: 12 months
MitraClip complications
12 months
Single-leaflet Device Detachments
Time Frame: 12 months
Device-related MitraClip complications: Total number of single-leaflet device detachment events.
12 months
Device Embolizations (MitraClip)
Time Frame: 12 months
Device-related MitraClip complications: Total number of device embolizations.
12 months
Endocarditis (Requiring Surgery)
Time Frame: 12 months
Device-related MitraClip complications: Total number of endocarditis events requiring surgery.
12 months
Mitral Stenosis (Requiring Surgery)
Time Frame: 12 months
Device-related MitraClip complications: Total number of mitral stenosis events requiring surgery.
12 months
Device- or System-related Failures
Time Frame: 12 months
Device-related CardioMEMS complications: Total number of device- or system-related failures.
12 months
In Situ Pulmonary Thrombosis
Time Frame: 12 months
Device-related CardioMEMS complications: Total number of in situ pulmonary thrombosis.
12 months
Device Embolizations (CardioMEMS)
Time Frame: 12 months
Device-related CardioMEMS complications: Total number of device embolizations
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Abbott

Investigators

  • Principal Investigator: Nir Uriel, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 27, 2024

First Submitted That Met QC Criteria

January 27, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 27, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU9731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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